Identity
- Trade Name
- Ster-ASSIST ™ FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- Introcan Safety® 18 Ga. x 2.5 in., Straight, FEP and CARESITE® Extension Set with bonded CARESITE Luer Access Device, Spin-Lock® connector, 8 in. (20cm). For use with power injector FDA UDI
- Model / Reference
- 375510 FDA UDI
- Description
- Introcan Safety® 18 Ga. x 2.5 in., Straight, FEP and CARESITE® Extension Set with bonded CARESITE Luer Access Device, Spin-Lock® connector, 8 in. (20cm). For use with power injector FDA UDI
Identifiers
- Catalog Number
- 375510 FDA UDI
- Primary DI / UDI-DI
- 04046964712890 FDA UDI
- FDA Product Code
- OWL FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Peripheral vascular intervention infusion catheter
Ster-ASSIST ™ by B. Braun Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular intervention infusion catheter.
- UniFuse — ANGIODYNAMICS, INC · Class II
- PowerMidline — Bard Access Systems, Inc. · Class II
- Cragg McNamaraTM — Micro Therapeutics, Inc. · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Fountain® — Merit Medical Systems, Inc. · Class II
- MINNIE — TELEFLEX INCORPORATED · Class II
- Cragg Mc-Namara Valved Infusion Catheter — Micro Therapeutics, Inc. · Class II
- Midline Catheter Kit — Bard Access Systems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- B. Braun Medical Inc.
Sources (1)
- FDA UDI 7f74e892-0aa0-4e47-8e75-02288e17f4b3 37 fields · synced May 30, 2026